New Commitment Policy

Background:

The HPV Challenge Program was established in 1998 in response to several studies that revealed how little health and environmental effects data were publicly available for HPV chemicals. EPA responded by inviting U.S. manufacturers and importers of HPV chemicals to voluntarily sponsor chemicals in the HPV Challenge Program. To become a sponsor, companies were asked to send a letter to EPA announcing its commitment to participate in the HPV Challenge Program and its willingness to adhere to the Program's procedures. The letter was also to specify the following:

The names and Chemical Abstract Service (CAS) numbers of the chemicals or categories the company will sponsor;

The name and contact data (address, telephone number, email address) for the technical person within the company who may be reached for any additional information; and

EPA has received numerous commitments to sponsor chemicals since the beginning of the Program in late 1998. The Agency extended the initial timeframe for commitments to be received from March 1999 to December 26, 2000. The December 26, 2000, date was chosen because it was the date on which a proposed TSCA Section 4 test rule containing 37 unsponsored chemicals was published. A total of 1,324 chemicals were sponsored on or before December 26, 2000, by 358 companies and 99 consortia. Commitments received after December 26, 2000, were deemed "viable commitments." In addition to submitting a commitment letter, a test plan, and robust summaries of existing studies, companies agreeing to sponsor chemicals through "viable commitments" also commit to provide full citations of published studies, full copies of unpublished studies, and full copies and robust summaries of any newly conducted studies. A total of 69 chemicals were sponsored after December 26, 2000, by 46 companies and 13 consortia. In addition, 861 chemicals have been sponsored indirectly in the HPV Challenge Program through commitments made in the ICCA HPV Initiative.

Accepting New Commitments:

As the HPV Challenge Program nears completion, EPA continues to encourage commitments from U.S. manufacturers and importers of chemicals that are currently unsponsored (i.e., orphan chemicals). However, in response to a recommendation by the Interagency Testing Committee (ITC) in its 55th Report to the EPA Administrator, the Agency is currently developing a Toxic Substances Control Act (TSCA) 8(a) Preliminary Assessment and Information Reporting (PAIR) rule and a TSCA 8(d) Health and Safety Data Reporting (HaSDR) rule that will be designed to gather data for HPV Challenge Program chemicals that remain unsponsored. The Agency will accept new commitments to sponsor chemicals under the HPV Challenge Program within 14 days following publication of those "direct final" rules in the Federal Register (expected August 2005). Chemicals for which commitments are made within 14 days following publication of these rules will be removed from those rules prior to their effective date (i.e., 30 days) following publication in the Federal Register. EPA will promulgate subsequent 8(a) PAIR and 8(d) HaSDR rules if commitments are not met. These new commitments will continue to be considered as "viable commitments", however, the Agency will not expect companies to provide full copies of studies unless requested. The status of these new commitments, including any that may be withdrawn will be noted on the HPV Challenge Website at http://www.epa.gov/hpv/.

Thus, such "viable commitments" will include, in addition to a commitment letter, the submission of robust summaries of existing studies, full citations of published studies, full copies of unpublished studies when requested by EPA, and a test plan for filling data gaps as is currently prescribed under the HPV Challenge Program. The test plans will undergo a 120-day public review as per the HPV Challenge Program procedures. These submissions are due as soon as possible, but no later than 60 days from the effective date of the HPV orphan chemical TSCA section 8(a) PAIR and section 8(d) HaSDR rules. If this date is not met, EPA may proceed to promulgate additional 8(a) and 8(d) rules without further notice and may begin TSCA section 4 test rule development for those chemicals where the requisite statutory findings can be made. Additionally, in order to be considered a viable commitment, any new testing must be completed and the robust summaries must be submitted as soon as possible but no later than 24 months from the effective date of the HPV orphan chemical TSCA section 8(a) PAIR rule and the 8(d) HaSDR rule. Full copies of studies for these viable commitments should be provided when requested by EPA. If the commitment is not met, EPA may begin TSCA section 4 test rule development for those chemicals where the requisite statutory findings can be made. If the sponsor encounters delays beyond their control, they are asked to notify EPA immediately.

Commitments on chemicals subject to the HPV orphan chemical 8(a) PAIR and 8(d) HaSDR rules that are made by companies after the 14th day following publication of these rules will include, in addition to all submissions expected for "viable commitments," robust summaries for all relevant health and safety studies submitted to EPA by all respondents to the TSCA section 8(d) HaSDR rule. All sponsor submissions in this case, with the exception of any new testing, will be due as soon as possible but no later than 120 days1 from the effective date of the HPV orphan chemical TSCA section 8(a) PAIR and section 8(d) HaSDR rules. The submitted test plans will undergo a 120-day public review. In order to be considered a viable commitment, any new testing must be completed and the robust summaries and complete copies of these studies must be submitted as soon as possible but no later than 24 months from the effective date of the HPV orphan chemical TSCA section 8(a) PAIR and 8(d) HaSDR rules.

On March 16, 2006, EPA issued the final TSCA section 4 rule that was proposed for certain unsponsored chemicals on December 26, 2000. Additional TSCA section 4 test rules are under consideration to fill data needs that remain unmet in the voluntary HPV Challenge Program or through two complementary international initiatives, the OECD HPV SIDS Program and the ICCA HPV Initiative. EPA will continue to evaluate the extent to which unsponsored HPV chemicals (as well as sponsored chemicals for which commitments are not met by the sponsor) should be identified for rulemaking under TSCA section 4.

1 EPA has modified the amended Policy posted on this site on August 16, 2006, with regards to submissions under commitments that are made after the 14th day following publication of the HPV orphan chemical TSCA section 8(a) PAIR and section 8(d) HaSDR rules. Specifically, EPA is extending the submission date to 120 days from the effective date of the HPV orphan chemical TSCA section 8(a) PAIR and section 8(d) HaSDR rules (rather than the 60 days in the August 16, 2006 amendment). This 120-day period of time should ensure that a sponsor has sufficient time to obtain and review all relevant health and safety studies submitted to EPA by all respondents to the TSCA section 8(d) HaSDR rule.